Sr. Director, Compliance & Strategy, MQSA
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What you'll do
- Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents (GPOs) spanning sterile, aseptic, and microbial control practices across all modalities and manufacturing environments
- Provide site Environmental and Aseptic Control (EAC) governance and oversight, ensuring alignment with enterprise standards and regulatory expectations
- Define, maintain, and continuously improve the enterprise contamination control requirements and risk methodologies applicable to all product types and manufacturing settings
- Govern compliance gap assessments and applicability matrices for aseptic processes, microbial control, and SA requirements across the internal and external manufacturing network
- Drive adoption of enterprise standards into site-level operations, ensuring practical, scalable and sustainable implementation
- Define the enterprise aseptic and microbial control roadmap, including long-range strategic objectives, KPIs, and performance monitoring frameworks
- Own the enterprise contamination control strategy, CCS frameworks, and harmonization roadmap — integrating sterile, aseptic, and non-sterile manufacturing programs into a cohesive, risk-based enterprise approach
- Identify and evaluate emerging aseptic processing and microbial control technologies, driving industry benchmarking and innovation adoption into enterprise strategy
- Provide centralized aseptic and microbial control technical oversight across the full manufacturing network, including internal sites and contract partners
- Define, maintain, and govern enterprise aseptic and microbial regulatory intelligence and surveillance programs, including systematic interpretation of evolving global regulations, guidance, and expectations related to aseptic processing, contamination control, and microbial quality
- Drive and own change notification, compliance alignment, and regulatory change impact assessments to ensure timely enterprise readiness for evolving regulatory requirements related to aseptic processing
- Lead enterprise aseptic and microbial control regulatory engagement strategy in both sterile and non-sterile manufacturing contexts, including engagement with health authorities and industry bodies
What they're looking for
- Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
- 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
- Minimum 8–10 years in senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy
- Deep experience across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy
- Demonstrated expertise in global regulatory frameworks (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP <797>/<1072>/<71>, PIC/S, and other applicable guidance)
- Proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent)
- Experience governing CMO/CDMO quality relationships and aseptic compliance requirements
- Track record of successfully leading enterprise-wide harmonization and change management programs
Nice to have
- Advanced degree (M.S. or Ph.D.) in Microbiology or a related field
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Key Responsibilities
Enterprise Governance & Frameworks
Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents (GPOs) spanning sterile, aseptic, and microbial control practices across all modalities and manufacturing environments
Provide site Environmental and Aseptic Control (EAC) governance and oversight, ensuring alignment with enterprise standards and regulatory expectations
Define, maintain, and continuously improve the enterprise contamination control requirements and risk methodologies applicable to all product types and manufacturing settings
Govern compliance gap assessments and applicability matrices for aseptic processes, microbial control, and SA requirements across the internal and external manufacturing network
Drive adoption of enterprise standards into site-level operations, ensuring practical, scalable and sustainable implementation
Strategy, Roadmap & Performance
Define the enterprise aseptic and microbial control roadmap, including long-range strategic objectives, KPIs, and performance monitoring frameworks
Own the enterprise contamination control strategy, CCS frameworks, and harmonization roadmap — integrating sterile, aseptic, and non-sterile manufacturing programs into a cohesive, risk-based enterprise approach
Identify and evaluate emerging aseptic processing and microbial control technologies, driving industry benchmarking and innovation adoption into enterprise strategy
Provide centralized aseptic and microbial control technical oversight across the full manufacturing network, including internal sites and contract partners
Regulatory Intelligence & Compliance Alignment
Define, maintain, and govern enterprise aseptic and microbial regulatory intelligence and surveillance programs, including systematic interpretation of evolving global regulations, guidance, and expectations related to aseptic processing, contamination control, and microbial quality
Drive and own change notification, compliance alignment, and regulatory change impact assessments to ensure timely enterprise readiness for evolving regulatory requirements related to aseptic processing
Lead enterprise aseptic and microbial control regulatory engagement strategy in both sterile and non-sterile manufacturing contexts, including engagement with health authorities and industry bodies.
Provide regulatory interpretation support for internal audits and regulatory inspections, ensuring consistent, defensible, science-based responses.
Inspection Readiness & Technical Compliance Support
Support regulatory inspection readiness at internal manufacturing facilities and contract manufacturers, serving as a subject matter expert resource during health authority inspections.
Provide general and microbiological technical compliance support related to regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness activities.
Serve as an enterprise escalation point for complex or high-risk microbial and sterility assurance compliance matters.
CMO/CDMO Governance
Define contractual and quality agreement requirements for CMO/CDMO aseptic practices, sterility assurance, and microbial control obligations, ensuring external partners meet BMS enterprise standards and applicable regulatory expectations.
Oversee compliance assessments and audits of external manufacturing partners related to aseptic and microbial control performance.
Training, Capability & Competency Development
Define and govern enterprise requirements for aseptic training, capability development, and competency assurance, including aseptic technique qualification, gowning qualification, and annual requalification programs.
Maintain and continuously improve the global aseptic training program, content library, and qualification frameworks across all manufacturing sites and personnel categories.
Foster a culture of aseptic discipline, contamination awareness, and quality mindset across the manufacturing network.
Ensure training programs translate into demonstrable improvements in aseptic behaviors, contamination control practices, and inspection readiness.
External Engagement & Industry Leadership
Lead external engagement with regulatory agencies, industry consortia, and professional organizations (e.g., PDA, ISPE, USP expert committees) to shape industry standards and best practices.
Represent BMS in benchmarking initiatives and emerging science forums related to aseptic processing and microbial control.
Qualifications & Experience
Education
Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
Experience
15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
Minimum 8–10 years in senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy
Deep experience across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy
Demonstrated expertise in global regulatory frameworks (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP <797>/<1072>/<71>, PIC/S, and other applicable guidance)
Proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent)
Experience governing CMO/CDMO quality relationships and aseptic compliance requirements
Track record of successfully leading enterprise-wide harmonization and change management programs
Competencies & Skills
Exceptional scientific and technical depth in aseptic processing, contamination control, microbial quality, and sterility assurance
Strong strategic thinking and ability to translate complex scientific and regulatory requirements into actionable enterprise frameworks
Proven ability to influence without direct authority across a global, matrixed organization
Executive-level communication and presentation skills; ability to engage credibly with health authorities, senior leadership, and external partners
Strong risk assessment and decision-making capabilities in ambiguous and high-stakes environments
Demonstrated ability to build, lead, and develop high-performing, globally dispersed teams
Preferred:
Advanced degree (M.S. or Ph.D.) in Microbiology or a related field
#LI- Hybrid
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1606479 : Sr. Director, Compliance & Strategy, MQSA
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